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Cllinical Trial Manager

Company: Robsco Search
Location: Newark
Posted on: October 18, 2020

Job Description:

The Clinical Trial Manager will manage all operational aspects for implementation of clinical trial activities from study start-up through database lock, ensuring GCPs and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate. The incumbant may also be called upon to help mentor or guide less-senior staff. Responsibilities oPartners with Sourcing department in RFP process, identifies scope of work, study contracting needs, CRO selection process, o provides input into vendor management plan, reviews quality metrics and shares lessons learned. oManages and executes vendor kick off meetings, face-to-face meetings, team training, and trial webex as required for trial oexecution. oReviews and oversees the development, review and operational aspects of site investigator grant and grant payment in oaccordance with sponsor process requirements. oTracks and obtains necessary approvals related to vendor contract change orders. oProvides operational review and content to the study protocol and coordinates completion of QC review of the protocol. oLeads and/or supports clinical operational team meetings in support of the respective clinical trial including: drafting agenda, ocollect minutes, filing minutes in the TMF, tracking action items, providing ongoing status of trial enrollment and timelines, ooutlining vendor related deliverables, communicating risk/issues, and managing input from other internal and external partners. oCoordinates and manages investigator meetings including development of the agenda, management of slide development oand review, coordination of meeting planner activities, and presenting at investigator meeting. oConducts thorough review of key specification documents related to the trial and oversees/participates in the UAT for IWR, oEDC, eDiary and other systems. oProvides content for study related systems and portals. oServes as the clinical operations representative on team meetings held by other functions and provides necessary input into key process related documents. oConducts monitoring/co-monitoring of investigative sites as applicable. oApproves study invoices related to trial vendors. oProvides input into and/or develops study related materials such as Clinical Monitoring Plans, Data Management Plans, oeCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, oand approval for site receipt of study drug. oPerforms and/or coordinates designees in processes related to designees monitoring report review, protocol deviations and odata listings for sponsored studies to ensure reliable quality data are delivered. oCoordinates the CROs on site selection, IRB submissions, site initiation and close-out planning. oTracks patient recruitment and progress to study timelines; supports site receipt of safety reporting; maintains and reports ometrics for clinical study and CRO delivery performance. oPerforms and/or oversees site monitoring visits for clinical trials as needed including and not limited to ensuring clinical osupplies accountability records are maintained. oProvides oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP oquality standards and consistency with company SOPs. oProvides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring. Supports QA and regulatory agency activities related to trial related audits pertaining to clinical executions (e.g. sites, TMF, etc.) Qualifications: Bachelors degree in health or biologic science (BS/BA/BScN); masters-level degree is preferred.Minimum of 5 years of clinical study management experience in the biopharmaceutical industry, including a minimum of 2 years as a clinical study lead/project manager; global clinical trial experience is highly preferred.Experience in management of contracted resources/CROs, site monitoring and clinical quality compliance.Strong CRO oversight and operational management skills with proven attention to detail.Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is preferred.Effective oral/written communication and interpersonal skills.Advanced computer skills including proficiency in MS Office. Willingness to travel up to 20% including domestic and international travel

Keywords: Robsco Search, Newark , Cllinical Trial Manager, Executive , Newark, New Jersey

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